Velocity Pharma LLC

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

your firm failed to have adequate procedures to ensure all ophthalmic drug products produced for your firm met appropriate quality attributes. You also failed to have adequate supplier qualification procedures to ensure that the drug products received from Kilitch and (b)(4) were manufactured in compliance with CGMP prior to being distributed in the United States.

Passage 2

your firm’s records for the distribution of finished drug products are deficient. For example, during the inspection of your facility, you provided distribution records that were missing addresses, batch numbers, and quantities shipped from your facility.

Passage 3

As a distributor of Kilitch Healthcare India Limited products in the U.S. market, you failed to take action to remove adulterated products from the market, including your own-label Velocity Pharma products.